BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIVAC XL ARTHROWAND

    MDR report key: 1378309 · Received May 11, 2009

    Report

    Report Number
    2951580-2009-00036
    Event Type
    Other
    Date Received
    May 11, 2009
    Date of Event
    April 1, 2009
    Report Date
    May 7, 2009
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE DEVICE HAS BEEN RETURNED AND COMPLETION OF THE INVESTIGATION. TWO DEVICES, MULTIVAC XL ARTHROWAND ARTHROWANDS, WERE USED IN THE SAME PROCEDURE. TWO SEPARATE MDR REPORTS WILL BE FILED UNDER MDR 2951580-2009-00036, AND MDR 2951580-2009-00039.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING TWO MULTIVAC XL ARTHROWANDS WAS REPORTED TO ARTHROCARE CORPORATION. DURING A HIP ARTHROSCOPY PROCEDURE, THE ELECTRODES DETACHED FROM THE TIP OF TWO WANDS IN THE SURGICAL SITE. THE ELECTRODES REMAIN IN THE PATIENT'S HIP JOINT. THERE WAS NO INJURY TO THE PATIENT AND NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVAC XL ARTHROWAND ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other